MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-18 for VERSACELL X3 SAMPLE MANAGEMENT SYSTEM manufactured by Siemens Healthcare Diagnostics Inc..
[60448378]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse retrieved the sample tube and tested it on all the racks, which read correctly. The cse verified that the racks were reading appropriately during normal operations and no error was detected. The cause of the sample barcode being misread is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[60448379]
The operator of a versacell x3 sample management system reported that a sample barcode was misread. A sample tube with accession # (b)(6) was read incorrectly as (b)(6). The original sample tube with accession # (b)(6) was read earlier on the same day. Sample tubes with accessions #s (b)(6) were not detected as duplicates. The error was observed after the sample was loaded and prior to any tests being assigned to the incorrect barcode. There are no known reports of patient intervention or adverse health consequences due to the sample barcode being misread.
Patient Sequence No: 1, Text Type: D, B5
[63934371]
The initial mdr 2247117-2016-00078 was filed on november 18, 2016. Additional information (11/05/2016): a siemens customer service engineer (cse) revisited the customer site. The cse determined that the samples which fitted into the racks had the barcode partially hidden. The cse placed the samples with barcode exposed but the peripheral barcodes were not read. The cse then adjusted the barcode beam width and verified that the barcode reader was reading the samples normally. The instrument is performing within manufacturing specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2016-00078 |
| MDR Report Key | 6113105 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-18 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-11-05 |
| Device Manufacturer Date | 2015-10-22 |
| Date Added to Maude | 2016-11-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSACELL X3 SAMPLE MANAGEMENT SYSTEM |
| Generic Name | SAMPLE MANAGEMENT SYSTEM |
| Product Code | CGJ |
| Date Received | 2016-11-18 |
| Model Number | VERSACELL X3 SAMPLE MANAGEMENT SYSTEM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-18 |